Months Since Onset

Non-Invasive Ventilation (NIV)

Diaphragm Pacer (DPS)

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?

Unknown

Update Notes:

6/8/2018

Trial added

Locations:

Chiba University Hospital , Chiba

Ioh National Hospital , Ishikawa

Juntendo University Hospital , Tokyo

Kitasato University East Hospital , Kanagawa

Kobe Central Munincipal Medical center , Hyogo

Miyoshi Neurological Clinic , Hiroshima

Murakami Karindo Hospital , Fukuoka

Nagoya University Hospital Nagoya, Nagoya, 466-8560

Okayama University Hospital , Okayama

Sapporo Medical University Hospital , Hokkaido

Shiga Medical University Hospital , Shiga

Teikyo University Hospital , Tokyo

Toho University Hospital , Tokyo

Tokushima University Hospital , Tokushima

Tokyo Metropolitan Neurological Hospital , Tokyo

Wakayama Medical University Hospital , Wakayama

Other Information:

Purpose:

Purpose:
To examine the clinial efficacy and safety of ultra-high dose (50mg, im, twice a week) methylcobalamin in retarding the progression of symptoms in amyotrophic lateral sclerosis (ALS) patinets, we enroll ALS patients diagnosed by revised-Awaji-El Escorial criteria within 12 months after the clinical onset. First they are followed for 12 weeks with ALSFRSR scores, and only those who exhibit drops of 1-2 points are allowed to enter into the test period. A total of 128 patients are randomized and the half having placebo. They are blindly evaluated for drops of ALSFRS in 16 weeks, as the primary outcome. After this, all subjects receive methylcobalamin.

Eligibility:

Eligibility:
20 Years and older, all genders, not accepting healthy volunteers